FDA 483 - BioLife Plasma Services LP - January 31, 2020

An FDA inspection of Biolife Plasma Services L.P. in Springfield, MO, revealed a critical failure to ensure plasmapheresis donors met eligibility criteria. Specifically, a donor with a history of male-to-male sexual contact falsely answered health history questions and was not deferred even after this information was disclosed. This indicates a significant lapse in donor screening and eligibility protocols at the facility.